PRENATVITE by SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS PRENATVITE tablet

PRENATVITE by

Drug Labeling and Warnings

PRENATVITE by is a Other medication manufactured, distributed, or labeled by SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

SUPPLEMENT FACTS:

Serving Size: One Tablet

PRENATVITE RX is an orally administered prenatal dietary Supplement and should be administered under the supervision of a licensed medical practitioner.

Each PRENATVITE tablet contains:
VITAMIN A (AS ACETATE, BETA CAROTENE)		1200 MCG
VITAMIN C (ASCORBIC ACID)		120 MG
VITAMIN D3 (AS CHOLECALCIFEROL)		10 MCG
VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)		4.6 MG
VITAMIN B1 (AS THIAMINE MONONITRATE)		1.5 MG
VITAMIN B2 (AS RIBOFLAVIN)		1.7 MG
VITAMIN B3 (AS NIACINAMIDE)		18 MG
VITAMIN B6 (AS PYRIDOXINE HCL)		2.6 MG
FOLIC ACID		800 MCG
VITAMIN B12 (AS CYANOCOBALAMIN)		4 MCG
CALCIUM (AS CALCIUM CARBONATE & SULFATE)		263 MG
IRON (AS FERROUS FUMARATE)		27 MG
ZINC (AS ZINC OXIDE)		25 MG
INOSITOL		5 MG
CITRUS BIOFLAVONOIDS COMPLEX 50%		2 MG
BORON (AS BORON CITRATE)		0.2 MG

Other Ingredients:

MICRO CRYSTALLINE CELLULOSE, DI CALCIUM PHOSPHATE, STEARIC ACID, CROSCARMELLOSE SODIUM, SILICON DIOXIDE, MAGNESIUM STEARATE, HPMC E15, HPMC E5/E6, PEG - 8000, TALC, FD&C RED # 40 (LAKE), FD&C YELLOW # 6 (LAKE), TRIACETIN.

INDICATIONS
PRENATVITE RX is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

CAUTION: High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.
PRECAUTIONS
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid
DOSAGE AND ADMINISTRATION

One tablet daily or Take exactly as prescribed by your doctor. Take PRENATVITE RX tablet each day at any time of day at about the same time each day. PRENATVITE RX can be taken with or without food.
STORAGE
Store at 20-25°C (68-77°F) [See USP controlled room temperature].
Do not keep medicine that is out of date or that you no longer need.
Keep PRENATVITE RX Tablets and all medicines out of the reach of children.
NOTICE
Contact with moisture can discolor or erode the tablet.

HEALTH CLAIM

HOW SUPPLIED

Bottles of 90 tablets each - NDC: 73317-1050-9

To report a serious adverse event or obtain product information, call 631-524-5758

Call your licensed medical practitioner about side effect.

You may report side effects by calling AUM 1-631-524-5758.

Manufactured and Distributed by:

AUM Pharmaceuticals
Hauppauge, NY 11788.

Made in USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRENATVITE 
prenatvite tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:73317-1050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1200 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	4.6 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	18 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	2.6 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	800 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	4 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749)	INOSITOL	5 mg
CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O)	CITRUS BIOFLAVONOIDS	2 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	263 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q)	BORON	0.2 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:73317-1050-9	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		02/03/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	5 mm

Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS		081225162	repack(73317-1050)